ZOLPIDEM VIATRIS 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Zolpidem Viatris 10 mg film-coated tablets EFG

zolpidem tartrate

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Zolpidem Viatris and what is it used for
2. What you need to know before you take Zolpidem Viatris
3. How to take Zolpidem Viatris
4. Possible side effects
5. Storage of Zolpidem Viatris
6. Contents of the pack and other information

1. What is Zolpidem Viatris and what is it used for

Zolpidem is a hypnotic that belongs to a group of medicines known as benzodiazepine analogs.

Zolpidem is used for the short-term treatment of insomnia in adults, in situations where insomnia is debilitating or causing severe anxiety.

Do not take this medicine for a long time. Treatment should be as short as possible, because the risk of dependence increases with the duration of treatment.

Zolpidem is indicated for disorders in the sleep rhythm and for all forms of insomnia, especially when there are difficulties in falling asleep, either initially or after a premature awakening.

2. What you need to know before you take Zolpidem Viatris

Do not takeZolpidem Viatris

• If you are allergic to zolpidem, to the group of benzodiazepines in general, or to any of the other components of this medicine (listed in section 6).
• If you have acute and/or severe respiratory difficulties.
• If you suffer from severe muscle weakness (myasthenia gravis).
• If you suffer from sleep apnea (a condition in which your breathing is interrupted for very short periods of time while you sleep).
• If you have any liver or kidney disorder.
• As long-term treatment. Treatment should be as short as possible, because the risk of dependence increases with the duration of treatment.
• If you have experienced sleepwalking or other unusual behaviors while sleeping (such as driving, eating, making phone calls, or having sex, etc.) without being fully awake after taking zolpidem or other medicines that contain zolpidem.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Zolpidem Viatris.

• Your doctor should identify the causes of insomnia whenever possible and treat the underlying factors before prescribing zolpidem.
• After taking zolpidem, you should ensure that you can have an uninterrupted sleep period of 8 hours to reduce the risk of anterograde amnesia (not remembering what happened while you were awake).
• If you have ever had any mental disorder or problems of abuse or dependence on alcohol or drugs.
• Risk of dependence: the use of zolpidem may lead to the development of abuse and/or physical and psychological dependence. The risk of dependence is greater when zolpidem is used for more than 4 weeks. The risk of abuse and dependence is greater in patients with a history of mental disorders and/or abuse of alcohol, illicit substances, or drugs.
• To minimize the risk of dependence, the following precautions should be taken:

• The intake of these medicines will only be done under medical prescription (never because they have been effective in other patients) and will never be recommended to other people.
• Do not increase the prescribed doses by the doctor, nor prolong the treatment for longer than recommended.
• Consult your doctor regularly, so that he decides whether to continue treatment.

Once physical dependence has developed, sudden interruption of treatment will be accompanied by a withdrawal syndrome, which may consist of the appearance of restlessness, anxiety, headache, muscle pain, confusion, irritability, and tension. Therefore, it is recommended to gradually reduce the dose, according to the doctor's instructions.

In severe cases, the following symptoms may appear: alteration of the perception of reality, depersonalization, decreased tolerance to usual sounds (hyperacusis), numbness and tingling in the limbs, hypersensitivity to light, noise, and physical contact, hallucinations, or epileptic convulsions.

• Rebound insomnia: in some cases, after interrupting treatment, a transient syndrome may occur in which the symptoms that led to starting treatment reappear, but in an increased form. They may be accompanied by other reactions such as mood changes, anxiety, sleep disorders, and restlessness. It is essential that you know that there is a possibility that this rebound phenomenon may occur, in order to minimize the anxiety that may be caused by the appearance of these effects when interrupting treatment. In the case of short-acting hypnotic/sedative medicines, the dose withdrawal phenomenon may appear within the dose interval. The probability of rebound insomnia is greater with sudden withdrawal. Therefore, it is recommended to gradually reduce the dose, according to the doctor's instructions.
• It is known that other psychiatric and "paradoxical" reactions such as restlessness, agitation, worsening of insomnia, irritability, aggressiveness, delirium, fits of rage, nightmares, psychosis, hallucinations, abnormal behavior, and other alterations of conduct occur with zolpidem. Treatment should be discontinued when these reactions appear. It is more likely that these reactions occur in elderly patients.
• Zolpidem may cause sleepwalking or other unusual behaviors while sleeping (such as driving, eating, making phone calls, or having sex, etc.) without being fully awake, some of which have been associated with serious injuries or even death. The next morning, you may not remember anything you did during the night. If you experience any of the above symptoms, discontinue treatment with zolpidem immediately and contact your doctor or healthcare professional, as these sleep behaviors can put you and others at serious risk of injury.

Drinking alcohol or taking other medicines that make you sleepy along with zolpidem could increase the risk of these sleep behaviors.

The use of zolpidem with alcohol and with other medicines that act on the central nervous system, or taking higher doses than the recommended dose, may increase the risk of these behaviors. Your doctor should consider discontinuing treatment in these cases, due to the risk it may pose to you and others.

• This medicine may cause drowsiness and a decrease in the level of consciousness, which can cause falls and, consequently, cause serious injuries.

• After repeated use for a few weeks, some tolerance to the product may appear, so it may lose some of its hypnotic effects.
• If you have a history of drug or alcohol dependence, you should not take zolpidem unless your doctor indicates it.
• If you have congenital long QT syndrome, your doctor should carefully consider the benefit/risk ratio before starting treatment with zolpidem.
• In patients with mental illnesses (psychosis), its use is not recommended as primary treatment.
• If you have suicidal tendencies and depression, it should be used with extreme caution. Consult your doctor before using this medicine, as it may uncover existing depression. Some studies have shown an increased risk of suicidal ideation, suicide attempt, and suicide in patients taking certain sedatives and hypnotics, including this medicine. However, it has not been established whether this is caused by the medicine or if there may be other reasons. If you have suicidal thoughts, contact your doctor as soon as possible for additional medical advice.
• If you have any liver disorder or respiratory problems, your doctor will decide whether it is convenient for you to take a lower dose of zolpidem or not to take it.
• In patients with severe liver insufficiency, zolpidem should not be taken, as it may contribute to the appearance of encephalopathy (brain disease).
• Do not take zolpidem at the same time as opioids (medicines used to relieve intense pain, such as morphine or codeine) unless your doctor prescribes it, due to the possible risk of suffering sedation, respiratory depression, coma, or even death (see "Other medicines and Zolpidem Viatris"). In the event that your doctor finally prescribes zolpidem concomitantly with opioids, he will prescribe the minimum effective dose and for the shortest time of concomitant use. Your doctor will monitor the appearance of signs and symptoms of respiratory depression and sedation.
• In elderly patients, the dose should be reduced. See section "3. How to take Zolpidem Viatris".

Psychomotor alteration the next day(see also "Driving and using machines")

Like other hypnotic/sedative medicines, zolpidem has depressant effects on the central nervous system.

The next day after taking zolpidem, the risk of psychomotor alteration may be increased, including the alteration of the ability to drive, if:

• You take this medicine with less than 8 hours of margin before performing activities that require a state of mental alertness.
• You take a higher dose than the recommended dose.
• You take zolpidem at the same time as another central nervous system depressant or another medicine that increases the concentration of zolpidem in the blood, combined with alcohol or with illegal substances.

Take the dose once and immediately before going to bed at night.

Do not take another dose during the same night.

Children and adolescents

Do not administer zolpidem to children and adolescents under 18 years of age.

Other medicines and Zolpidem Viatris

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

This is extremely important because the simultaneous use of more than one medicine can increase or decrease its effect.

Therefore, you should not use other medicines at the same time as zolpidem unless your doctor is informed and approves it previously.

• If you take zolpidem with the following medicines, effects such as drowsiness or psychomotor alteration the next day, including the alteration of the ability to drive, may be increased:

• Medicines for some mental disorders (antipsychotics).
• Medicines for sleep disorders (hypnotics).
• Medicines to relieve or reduce anxiety.
• Medicines for depression.
• Medicines for moderate to severe pain (narcotic analgesics).
• Medicines for epilepsy.
• Anesthetic medicines.
• Medicines for seasonal allergic rhinitis, skin rashes, or other allergies that can cause drowsiness (sedating antihistamines).

• If you take zolpidem with antidepressants, including bupropion, desipramine, fluoxetine, sertraline, and venlafaxine, you may see things that are not real (hallucinations).
• It is not recommended to take zolpidem with fluvoxamine or ciprofloxacin.
• If you take zolpidem with narcotic analgesics, it may produce an increase in euphoria, which could lead to an increase in psychological dependence.
• Opioid medicines: the use of zolpidem at the same time as opioids (potent analgesics, substitution therapy medicines, and some cough medicines) increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and can be potentially fatal. Due to this, concomitant use should only be considered when other treatment options are not possible. However, if your doctor prescribes zolpidem along with opioids, the dose and duration of concomitant treatment should be limited by your doctor.

Tell your doctor about all opioid medicines you are taking and follow your doctor's dosing recommendation closely. It may be useful to inform friends or relatives so that they are aware of the signs and symptoms indicated above. Contact your doctor when you experience such symptoms.

• Some medicines that inhibit/induce certain liver enzymes (CYP450) may affect the action of zolpidem.
• The concomitant administration with ketoconazole (used to treat fungal infections) may increase the sedative effects.
• The concomitant administration with rifampicin (used to treat infections) and with St. John's Wort may decrease the effect of zolpidem.
• The concomitant use of zolpidem with St. John's Wort is not recommended, as it may decrease the levels of zolpidem in the blood.
• The concomitant use with medicines that contain alcohol is not recommended. It may increase the sedative effect.

Taking Zolpidem Viatris with food and drinks

During treatment, avoid alcoholic beverages. The effect of alcohol may potentiate sedation and this may affect the ability to drive or operate machinery. If you need additional information on this point, consult your doctor.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy:

The use of zolpidem is not recommended during pregnancy.

If used during pregnancy, there is a risk that the baby may be affected. Some studies have shown an increased risk of cleft lip and palate (sometimes called "hare lip") in newborns.

Reduced fetal movement and fetal heart rate variability may occur after taking zolpidem during the second and/or third trimester of pregnancy.

If zolpidem is taken at the end of pregnancy or during delivery, the baby may show muscle weakness, a decrease in body temperature, difficulty feeding, and breathing problems (respiratory depression).

If this medicine is taken regularly at the end of pregnancy, the baby may develop symptoms of physical dependence and may be at risk of developing withdrawal symptoms such as agitation or tremors. In this case, the newborn should be closely monitored during the postnatal period.

Breastfeeding:

This medicine passes into breast milk, so you should not take zolpidem while breastfeeding your child.

Driving and using machines

Zolpidem is a sleep-inducing medicine. Do not drive or use machines if you feel drowsy or if you notice that your attention and reaction capacity are reduced. Pay special attention at the start of treatment or if the dose is increased.

Zolpidem has a significant effect on the ability to drive and use machines such as "driving while drowsy". On days when you take zolpidem (as with other hypnotics), you should consider the following:

• You may feel drowsy, sleepy, dizzy, or confused.
• You may take longer to make decisions.
• You may experience blurred or double vision.
• Your state of alertness may be decreased.

In order to reduce the aforementioned effects, a minimum margin of 8 hours is recommended between the administration of zolpidem and driving, using machinery, or performing any work at heights.

Do not consume alcohol or any other psychoactive substance while taking zolpidem, as this may increase the aforementioned effects.

Zolpidem Viatriscontains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Zolpidem Viatris

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is 10 mg of zolpidem every 24 hours. A lower dose may be prescribed for some patients. Zolpidem should be taken:

• once and
• right before bedtime.

Ensure that you leave a minimum margin of 8 hours from the time you take the medication until you engage in activities that require mental alertness.

Do not take more than 10 mg every 24 hours.

Elderly patients (over 65 years) or debilitated patients

The recommended dose is half a tablet, i.e., 5 mg. Do not exceed the recommended dose.

Patients with liver problems

The recommended initial dose is 5 mg. Your doctor may decide to increase it to 10 mg if considered safe.

Do not take zolpidem if you have severe liver problems.

Patients with respiratory problems

A lower dose is recommended for patients with respiratory problems.

Use in children and adolescents

Zolpidem should not be used in children and adolescents under 18 years.

Each individual dose should not exceed the indicated limits, and the total daily dose should not either, unless your doctor prescribes a higher dose.

Take zolpidem right before bedtime and swallow the tablet without chewing, with water or another non-alcoholic beverage.

Under normal conditions, you should not take more than 20 minutes to fall asleep after taking zolpidem, and it is convenient to ensure that you can rest without being awakened for at least 8 hours. Otherwise, although this happens rarely, it is possible that you will not remember what happened while you were awake.

In most cases, only short-term treatment with zolpidem is needed (generally, it should not exceed two weeks). The maximum treatment duration is four weeks, including gradual withdrawal of the medication. Treatment extension will not be performed without a reevaluation of your condition, as the risk of abuse and dependence increases with the duration of treatment (see section 2).

To avoid withdrawal symptoms, do not stop taking zolpidem abruptly, especially if you have been taking it for a long time.

If you think the effect of zolpidem is too strong or too weak, inform your doctor or pharmacist.

If you take more Zolpidem Viatris than you should

If you have taken more zolpidem than you should, consult your doctor or pharmacist immediately.

In cases of overdose involving zolpidem alone or with other central nervous system depressants (including alcohol), cases have been reported ranging from altered consciousness to coma and more severe symptoms, including death.

In moderate cases, symptoms include: drowsiness, mental confusion, and feeling of fatigue, exhaustion (lethargy). In more severe cases, symptoms may include lack of coordination (ataxia), decreased muscle tone (hypotonia), low blood pressure (hypotension), respiratory depression, cases of decreased consciousness to coma, and more severe symptoms, including a fatal outcome.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service: Phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Zolpidem Viatris

Do not take a double dose to make up for forgotten doses.

If you forget to take a dose, you should never try to correct it by taking a double dose the next time, but instead, continue with the normal dose.

If you interrupt treatment with Zolpidem Viatris

Abrupt interruption of treatment may produce withdrawal syndrome, which manifests as headache or muscle pain, anxiety, tension, restlessness, confusion, and irritability (see section "Warnings and precautions").

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medications, this medication can produce adverse effects, although not all people experience them.

Most patients tolerate zolpidem well, but some, especially at the beginning of treatment, feel somewhat tired or drowsy during the day.

The following criterion has been used for the classification of the frequency of adverse effects:

Very common: may affect more than 1 in 10 patients.

Common: may affect up to 1 in 10 patients.

Uncommon: may affect up to 1 in 100 patients.

Rare: may affect up to 1 in 1,000 patients.

Very rare: may affect up to 1 in 10,000 patients.

Frequency not known: cannot be estimated from the available data.

A relationship between adverse effects and dose has been demonstrated. These effects should be less if zolpidem is administered immediately before bedtime.

These effects are more frequent in elderly patients.

Immune system disorders

Frequency not known: allergic inflammation, which can be localized in feet, hands, throat, lips, and respiratory tract (angioneurotic edema).

Psychiatric disorders

Common: hallucinations, agitation, nightmares, depression.

Uncommon: confusional state, irritability, restlessness, aggressiveness, sleepwalking, mood elevation. Zolpidem may cause sleepwalking or other unusual behaviors while sleeping (such as driving, eating, making phone calls, or having sexual relations, etc.) without being fully awake, see section "Warnings and precautions".

Rare: changes in sexual desire.

Very rare: delirium, dependence (interruption of treatment may cause withdrawal symptoms or rebound effects).

Frequency not known: rage attacks, psychosis, abnormal behavior.

Nervous system disorders

Common: drowsiness, headache, dizziness, worsening of insomnia, cognitive disorders, such as anterograde amnesia (does not remember what happened while awake after taking the medication). Amnesia may be associated with inappropriate behavior.

Uncommon: tingling sensation, numbness (paresthesia), tremor, attention disturbance, speech disorder.

Rare: decreased level of consciousness.

Eye disorders

Uncommon: double vision, blurred vision.

Rare: visual impairment.

Respiratory, thoracic, and mediastinal disorders

Very rare: breathing difficulties (respiratory depression).

Gastrointestinal disorders

Common: diarrhea, nausea, vomiting, abdominal pain.

Hepatobiliary disorders

Uncommon: increased liver enzymes.

Rare: liver damage (hepatocellular, cholestatic, or mixed injury).

Metabolic and nutritional disorders

Uncommon: appetite disorder.

Skin and subcutaneous tissue disorders

Uncommon: itching, skin rash, excessive sweating.

Rare: urticaria.

Musculoskeletal and connective tissue disorders

Common: back pain.

Uncommon: joint pain (arthralgia), muscle pain (myalgia), muscle spasms, neck pain, muscle weakness.

Infections and infestations

Common: respiratory tract infection (upper and lower respiratory tract infection).

General disorders and administration site conditions

Common: fatigue.

Rare: gait disturbances, falls (predominantly in elderly patients and when the doctor's recommendations are not followed).

Frequency not known: tolerance to the product.

Depression

The use of the medication may unmask existing depression. Since insomnia can be a symptom of depression, if insomnia persists, inform your doctor to evaluate your situation.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Zolpidem Viatris

Empty section

Keep this medication out of sight and reach of children.

This medication does not require special storage conditions.

Do not use this medication after the expiration date shown on the packaging after the abbreviation CAD or EXP. The expiration date is the last day of the month indicated.

Medications should not be thrown away in drains or trash. Deposit the packaging and medications you no longer need in the SIGRE point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Zolpidem Viatris

• The active ingredient is zolpidem. Each film-coated tablet contains 10 mg of zolpidem tartrate.
• The other ingredients are: lactose monohydrate, microcrystalline cellulose, pregelatinized corn starch, magnesium stearate, titanium dioxide (E-171), hypromellose 2910 (E-464), macrogol 400, polysorbate 80 (E-433), and purified water.

Appearance of the product and package contents

Zolpidem Viatris are film-coated tablets, oblong, white, scored, and marked with "ZM" and "10" on one side and with the letter "G" on the reverse.

They are presented in blister packs containing 30 or 500 film-coated tablets.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

Manufacturer:

Mylan Hungary Kft.

H-2900 Komárom

Mylan utca 1

Hungary

Date of the last revision of this prospectus:April 2024

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) https://www.aemps.gob.es/